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NCT Number: NCT05871658

Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Abstract Background Neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients, with no satisfactory treatment. Through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD are still scare.

Objective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with pain.

Materials and Methods In this exploratory randomized controlled study, NMOSD patients with pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled.

The experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes each. On the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α.

Conclusion This is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with NMOSD. The study will provide clincial evidence of the practice of electroacupuncture on NMOSD with pain.

Key Words neuromyelitis optica spectrum disorders; pain; electroacupuncture

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neurologic Manifestations Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.[21]
  • NRS≥4.
  • people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment.
  • people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment.
  • people or their families provided written informed consent.

Exclusion criteria

  • people enrolled in other clinical studies.
  • people with low cognitive or mental ability.
  • people who became pregnant during the study period, breastfed, or planned to become pregnant.
  • people with serious diseases related to the heart, liver, kidney or hematopoietic system.
  • people with diabetic peripheral neuropathy.

Treatment and study plan

electroacupuncture

Behavioral

electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.

Primary outcomes

  1. Short-Form of McGill Pain Questionnaire(SF - MPQ)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  2. Short-Form of McGill Pain Questionnaire(SF - MPQ)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

Secondary outcomes

  1. Expanded Disability Status Scale(EDSS)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  2. Expanded Disability Status Scale(EDSS)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

  3. numerical rating scale(NRS)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  4. numerical rating scale(NRS)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

  5. Self-Rating Anxiety Scale (SAS)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  6. Self-Rating Anxiety Scale (SAS)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

  7. Self-rating Depression Scale (SDS)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  8. Self-rating Depression Scale (SDS)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

  9. 36-item Short-Form (SF-36)

    Time frame: on the baseline

    higher scores mean a better outcome.

  10. 36-item Short-Form (SF-36)

    Time frame: through study completion, an average of 1 month

    higher scores mean a better outcome.

  11. Interleukin-6 (IL-6)

    Time frame: on the baseline

    higher scores mean a worse outcome.

  12. Interleukin-6 (IL-6)

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

  13. tumor necrosis factor-α （TNF-α）

    Time frame: on the baseline

    higher scores mean a worse outcome.

  14. tumor necrosis factor-α （TNF-α）

    Time frame: through study completion, an average of 1 month

    higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Yuanqi Zhao,MD

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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